{"id":1933606,"url":"https://alion.io/job/precision-medicine-group-quality-compliance-manager-computer-system-validation","title":"Quality & Compliance Manager, Computer System Validation","company":{"id":449981,"name":"Precision Medicine Group","domain":"precisionmedicinegrp.com","url":"https://alion.io/company/precision-medicine-group-2","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":86,"open_postings":19,"ghost_share":0,"stale_share":0.579,"repost_share":0,"time_to_fill_p50_days":42,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Management","role_family":"Management","seniority":"senior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":91500,"max":120000,"currency":"USD","period":"year","gross":null,"usd_annual":120000},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"CAPA","optional":false},{"name":"Chromatography","optional":false},{"name":"GCP","optional":false},{"name":"GLP","optional":false},{"name":"GMP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Incident Management","optional":false},{"name":"LIMS","optional":false},{"name":"Waterfall","optional":false}],"status":"live","first_seen_at":"2026-10-05T20:42:16Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-28T14:07:42Z","board_verified":true,"closed_at":null,"days_open":22,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":22},"description":"JOB SUMMARY\nThe Quality & Compliance Manager, Computer System Validation manages the quality oversight and lifecycle validation of GxP computerized systems supporting CRO and laboratory operations. The role partners with Quality, IT, system owners, operational teams, and external providers to ensure systems are fit for intended use, maintain data integrity, and remain compliant and inspection-ready from implementation through retirement. The Manager establishes consistent, risk-based computer system assurance practices and drives continuous improvement across clinical and laboratory environments.\nMAIN DUTIES & RESPONSIBILITIES\nProvide independent, risk-based Quality Assurance oversight of GxP computerized systems throughout the system lifecycle, from initial assessment and implementation through operation, periodic review, significant change, and retirement.\nReview and approve applicable validation and assurance deliverables, including system risk assessments, validation plans, requirements, traceability documentation, test evidence, deviations, validation summary reports, and release-readiness documentation. Confirm that testing is appropriately planned, executed, documented, and traceable without assuming responsibility for business-owned testing or project execution.\nEnsure computerized systems are fit for intended use, maintain data integrity, and comply with applicable internal procedures, client commitments, and regulatory requirements, including requirements relevant to electronic records, electronic signatures, audit trails, access controls, security, backup, archival, and record retention.\nProvide QA oversight for computerized systems supporting clinical research and laboratory activities, including clinical platforms, laboratory information systems, electronic laboratory notebooks, chromatography data systems, instrument software, interfaces, automated workflows, and associated data repositories, as applicable to the role’s scope.\nOversee the ongoing validated state of computerized systems by evaluating changes, incidents, deviations, corrective and preventive actions, upgrades, data migrations, periodic reviews, and decommissioning activities. Identify and escalate compliance or data-integrity risks and verify that appropriate remediation is completed and documented\nSupport the qualification and ongoing oversight of software, cloud, data, and computerized-system service providers. Partner with Quality, IT, Information Security, Clinical Operations, Laboratory Operations, system owners, and vendors to clarify accountabilities and ensure that adequate controls are established and maintained.\nDevelop, maintain, and improve policies, procedures, templates, tools, and training for computer system validation and computer software assurance. Promote consistent, scalable, and risk-based practices across CRO and laboratory environments.\nPrepare for and support sponsor audits, regulatory inspections, and internal audits involving computerized systems. Ensure validation records are complete, accurate, readily retrievable, and inspection-ready, and coordinate responses to observations within the role’s area of responsibility.\nEstablish and report meaningful metrics for validation status, lifecycle compliance, overdue activities, deviations, CAPAs, supplier performance, and emerging risks. Use trends and lessons learned to drive continuous improvement and communicate significant issues to Quality and business leadership.\nEDUCATION AND EXPERIENCE\nBachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or another relevant scientific or technical discipline.\nA minimum of six years of progressively responsible experience in Quality Assurance, computer system validation, computer software assurance, information technology quality, or related discipline within a regulated life sciences environment.\nDemonstrated experience providing independent QA oversight of GxP computerized systems throughout the system lifecycle, including initial risk assessment, validation planning, requirements, testing, traceability, release, change control, periodic review, incident management, data migration, and system retirement.\nExperience reviewing and approving computer system validation or assurance documentation, such as validation plans, system risk assessments, requirements specifications, test plans and evidence, requirements traceability matrices, deviations, validation summary reports, and change-control records.\nWorking knowledge of applicable regulatory requirements and industry expectations, including FDA electronic-record and electronic-signature requirements, EU Annex 11, ICH Good Clinical Practice, Good Laboratory Practice, and data-integrity principles.\nExperience supporting computerized systems used in CRO, clinical research, or laboratory operations, such as electronic data capture, clinical trial management, electronic trial master file, interactive response technology, laboratory information management, electronic laboratory notebook, chromatography data, quality management, and other GxP-regulated platforms.\nExperience with risk-based validation and assurance approaches for configurable commercial software, software-as-a-service solutions, hosted platforms, system interfaces, laboratory instrument software, and internally configured or developed solutions.\nExperience supporting supplier qualification, system or vendor audits, sponsor audits, regulatory inspections, and the assessment and remediation of computerized-system compliance observations.\nDemonstrated experience working collaboratively with system owners, Information Technology, Information Security, Clinical Operations, Laboratory Operations, Quality Assurance, vendors, and other stakeholders in a matrixed and geographically dispersed organization.\nOr equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.\n Preferred Education and Experience: \nMaster’s degree in life sciences, computer science, information systems, engineering, quality management, regulatory affairs, or related discipline.\nExperience working within a contract research organization, regulated laboratory, biotechnology, pharmaceutical, or medical-device organization.\nExperience providing QA oversight across multiple GxP environments, particularly GCP, GLP, GCLP, and GMP.\nExperience managing or developing a geographically dispersed or global validation and quality team.\nExperience with laboratory platforms and instrument software, including LIMS, ELN, CDS, data-acquisition systems, interfaces, and automated laboratory workflows.\nExperience with clinical platforms, including EDC, CTMS, eTMF, IRT/RTSM, eCOA/ePRO, safety databases, and related data integrations.\nExperience with Agile, Waterfall, or hybrid system-development methodologies and the application of risk-based quality controls within the system development lifecycle.\nExperience hosting or supporting health-authority inspections and sponsor audits involving computerized systems, electronic records, data integrity, or system validation.\nRelevant professional certification, such as ASQ Certified Quality Auditor, ASQ Certified Manager of Quality/Organizational Excellence, ISACA Certified Information Systems Auditor, or an equivalent quality, auditing, or computer-system validation credential.\nFamiliarity with current Good Automated Manufacturing Practice guidance and risk-based computer software assurance principles.\nPrecision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.\nReasonable estimate of the current range\n$91,500—$120,000 USD\nAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.\nPrecision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.\nIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .\nRecruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at  so we can investigate and take appropriate action.\nCandidates must be legally authorized to work in the country of employment without employer sponsorship.","description_format":"text","description_chars":10247,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Health insurance","Life insurance","Parental leave"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)","Precision Medicine","Laboratory Equipment"],"lifecycle":[{"event":"open","at":"2026-10-05T22:45:31Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 2 · green card filings: 2","filings_12m":2,"filings_prev_12m":3,"green_card_filings_12m":2,"median_offered_wage_usd":87500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":49,"band":"ok","label":"Likely open","p_open":1,"p_active":0.548,"p_room":0.9,"age_days":22,"expected_fill_days":42,"reasons":["conf:1","stale_co","win:mid","comp:brand"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":120000,"is_top_pay":false},"html_url":"https://alion.io/job/precision-medicine-group-quality-compliance-manager-computer-system-validation","json_url":"https://alion.io/job/precision-medicine-group-quality-compliance-manager-computer-system-validation.json","meta":{"generated_at":"2026-10-28T17:24:23Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":23658,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":449981},"rest":"https://alion.io/mcp/rest/get_company?id=449981"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fprecision-medicine-group-quality-compliance-manager-computer-system-validation"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fprecision-medicine-group-quality-compliance-manager-computer-system-validation"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fprecision-medicine-group-quality-compliance-manager-computer-system-validation"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/precision-medicine-group-quality-compliance-manager-computer-system-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fprecision-medicine-group-quality-compliance-manager-computer-system-validation"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1933606}},{"tool":"search_jobs","arguments":{"company":"precisionmedicinegrp.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1933606},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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